The following data is part of a premarket notification filed by Sta-set Corp. with the FDA for Sta-set Model 250 I.v. Flow Regulator.
| Device ID | K864229 |
| 510k Number | K864229 |
| Device Name: | STA-SET MODEL 250 I.V. FLOW REGULATOR |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | STA-SET CORP. 3715 VINEYARD DR. Houston, TX 77082 |
| Contact | Matthew O'boyle |
| Correspondent | Matthew O'boyle STA-SET CORP. 3715 VINEYARD DR. Houston, TX 77082 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1986-12-16 |